TalShu, When it comes to all things patent related I defer to your knowledge. I understand, from reading many of your prior posts, that patents often cover broad indications of use. Sometimes uses that the applicant doesn't intend to pursue. I agree that this patent should protect the CVD indication until it expires. I also agree that since this is primarily a composition patent the generic cannot use a skinny label end run.
The thing that I'm uncertain of is FDA requirements for the approval pathway that you referenced. Would we be required to file for all prior approved indications for EPA?
Sleven,
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